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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY

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BOSTON SCIENTIFIC CORPORATION JETSTREAM ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 112264-001
Device Problem Mechanical Problem (1384)
Patient Problems Embolism (1829); Ischemia (1942); Occlusion (1984); Sepsis (2067)
Event Date 07/26/2018
Event Type  Injury  
Event Description
It was reported that the patient experienced an embolism and complications. A 2. 1mm jetstream xc was selected for an atherectomy procedure in the popliteal artery above the knee in the left leg. Atherectomy was performed with blades down and blades up with the jetstream device; however atheroembolization occurred occluding the distal popliteal artery and tibial arteries. The physician noted that the device malfunctioned, possibly due to the short length of the lesion being treated. After embolectomy restoring flow to the posterior tibial artery (pta) and perineal there was diminished collateral flow to the foot from the anterior tibial artery (ata) and occluded distal popliteal artery (dpa). The patient had worse hemodynamics on follow up ultrasound with tbi dropping from. 2 to 0 and ultimately developed a critically ischemic limb and sepsis resulting in above knee amputation. The popliteal and tibial arteries were patent prior to treatment and immediately following atherectomy they were occluded. Aspiration embolectomy was then performed with a non-bsc aspiration catheter of the popliteal, ata, tpt, peroneal. Infusion of nitroglycerine, verapamil and tissue plasminogen activator (tpa) were administered. Angioplasty of the tibial arteries and pedal arteries was performed. An un-specified stent was placed in the popliteal artery. A 100cc visipaque contract was administered. Continuous iv drip and flush for sheath. No critical abnormalities were noted.
 
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Brand NameJETSTREAM ATHERECTOMY CATHETER
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key7842619
MDR Text Key119082677
Report Number2134265-2018-60538
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/26/2020
Device Model Number112264-001
Device Catalogue Number45007
Device Lot Number0021921357
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/04/2018 Patient Sequence Number: 1
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